Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487734
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2007-06-15
Brief Title:
Effect of Testosterone Replacement on Insulin Resistance
Sponsor:
McGuire Research Institute
Organization:
McGuire Research Institute
Study Overview
Official Title:
Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal Non-obese Men With Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome The metabolic syndrome includes three of the following five conditions 1 an elevated blood pressure greater than 13085 2 a triglyceride level greater than 150 mgdl 3 an HDL-cholesterol less than 40 mgdl 4 glucose levels greater than 100 mgdl and 5 a waist measurement greater than 40 inches
Detailed Description:
In this proposal we will examine the relationship between hypogonadism and insulin sensitivity The strongest relationship between hypogonadism and insulin resistance appears to reside in men with the metabolic syndrome who have a normal BMI The causal relationship between these two conditions is unknown Therefore we propose to determine if testosterone replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin sensitivity Data obtained from this preliminary investigation will hopefully result in a hypothesis that can be tested in a larger more rigorous trial in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None